PRS-080 / Palvella Therapeutics - LARVOL DELTA

First-in-human Phase I studies of PRS-080#22, a hepcidin antagonist, in healthy volunteers and patients with chronic kidney disease undergoing hemodialysis. (PubMed, PLoS One) - "PRS-080#22, a novel Anticalin protein with picomolar affinity for hepcidin, was safe and well-tolerated when administered to healthy volunteers and CKD patients at all doses tested. The drug exhibited linear pharmacokinetics, longer half-life in CKD patients in comparison to healthy volunteers as well as expected pharmacodynamic effects which hold promise for further clinical studies."

Clinical • Journal • P1 data

Phase 2a Study to Evaluate PRS-080 in Anemic Chronic Kidney Disease Patients (clinicaltrials.gov) - P2a; N=11; Completed; Sponsor: Pieris Pharmaceuticals GmbH; Recruiting ➔ Completed

Clinical • Trial completion

A PHASE IIA STUDY TO EVALUATE THE SAFETY, PK AND PD OF REPEATED ADMINISTRATIONS OF THE HEPCIDIN ANTAGONIST PRS-080 IN ANEMIC CHRONIC KIDNEY DISEASE PATIENTS UNDERGOING HEMODIALYSIS (EHA 2019) - "Promising results were achieved in terms of both iron mobilization and increased TSAT, as well as initial evidence of an increase in Hb levels in the higher dose group. Further studies to determine the optimal treatment regimen with PRS-080 are warranted."

Clinical • P2a data

"$PIRS PRS-080 slides as presented at #EHA24 #EHA2019" (@dhovekamp42)

Sustained plasma hepcidin suppression and iron elevation by Anticalin-derived hepcidin antagonist in cynomolgus monkey. (PubMed, Br J Pharmacol) - "In conclusion, we developed a dose-dependent and safe approach for the direct suppression of hepcidin, resulting in prolonged iron mobilization to alleviate iron restricted erythropoiesis that can address the root cause of ACD. PRS-080-PEG30 is currently in early clinical development."

Journal